IRB #

STUDY00020703

Title

[NCI CIRB] EA4181 - A Randomized 3-Arm Phase II Study Comparing 1.) Bendamustine, Rituximab and High Dose Cytarabine (BR/CR) 2.) Bendamustine, Rituximab, High Dose Cytarabine and Acalabrutinib (BR/CR-A), and 3.) Bendamustine, Rituximab and Acalabrutinib (BR-A) in Patients <= 70 Years Old with Untreated Mantle Cell Lymphoma

Principal Investigator

Stephen Spurgeon

Study Purpose

This study is being done to compare which of the following combination of cancer drugs most effectively treat Mantle Cell Lymphoma.

1. bendamustine, rituximab, and high dose cytarabine (BR/CR)
2. bendamustine, rituximab, high dose cytarabine, and acalabrutinib (BR/CR-A)
3. bendamustine, rituximab and acalabrutinib (BR-A)

Medical Condition(s)

Mantle Cell Lymphoma

Eligibility Criteria

1 - confirmed diagnosis of Mantle Cell Lymphoma within 6 weeks of randomization

2- Patients must have untreated histologically confirmed mantle cell lymphoma, with cyclin D1 (BCL1) expression by immunohistochemical stains and/or t(11;14) by cytogenetics or FISH. The diagnosis must be confirmed by formal hematopathology review at the enrolling center

3 - between the ages of 18 and 70 years of age

4 - Performance status score of 0-2

5- adequate organ and marrow function

Age Range

18 - 70

Healthy Volunteers Needed

No

Duration of Participation

10 years

Minors Included

No

Contact

Knight Information Line - trials@ohsu.edu or 503-494-1080

Sponsor

ECOG-ACRIN

Recruitment End

12/31/2022

Compensation Provided

No


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